Approved revisions · linked evidenceSample data · local simulation
Materials to batch release. One connected record.Illustrative workspace · not a production system
01 Open a record02 Run a workflow03 See what blocks an approval
Where the connection matters
The batch is finished. The review should not be starting from scratch.
When observations, material status, and source documents live in different systems, review becomes a search for what happened. Helix keeps the instruction, the actual work, and the supporting evidence connected from the start.
The work, connected
Connect development, the batch, and the decision.
Shared identities, effective revisions, and review rules connect each team’s work to the next decision.
01
Keep the development basis.
Link study conditions, samples, methods, and structured results to the recipe revision they support. Transfer the rationale and scale assumptions with the approved process.
Development recipes
Transfer packages
Parameter rationale
02
Receive with context.
Link supplier, material, lot, certificate, and receipt. Keep incoming stock in the right disposition state before it becomes eligible for use.
Supplier qualification
Lot & container identity
Hold and release
03
Execute the approved recipe.
Guide operators through the effective instruction, required inputs, measurements, and review gates. Capture actual values at the step where they matter.
Versioned MBR records
Material issue
Limits & prerequisites
04
Investigate in the same record.
Connect a deviation to its batch, material, step, and source evidence. Keep the decision and follow-up visible to the teams affected.
Deviations & actions
Linked investigations
Accountable reviewers
05
Review the evidence, in context.
Bring results, specifications, and missing evidence into one decision surface. Preserve the source revision behind each approval.
QC review queues
Evidence requirements
Decision history
06
Keep the method behind the result.
Connect sample preparation, method revision, reference materials, calculations, and instrument source files. Preserve the qualification and review basis for each analytical result.
A quality status becomes useful when the next operation respects it. Link disposition to material eligibility and the evidence required to release it.
THE INFORMATION
A held lot is visible in inventory.
THE OPERATIONAL CONTROL
Approved disposition before allocation
The allocation action checks the lot’s disposition and refuses the held stock.
The lot, release decision, reviewer, and resulting allocation stay linked.
Model → records → execution
Your terminology. Your rules. One foundation.
An entity definition shapes a record type. Your approved records hold the operating content. Execution captures what actually happened.
01 · ENTITY DEFINITION
Master Batch Record
Defines the structure and allowed behavior of records of this type.
Ingredients & quantities
Ordered steps
Measurement limits
Approval lifecycle
Type structure + lifecycle + actions 02 · APPROVED RECORD
MBR-104 · Rev 8
The approved recipe for Levocet 5 mg tablets, including blend time and material quantities.
A specific record and its effective revision 03 · EXECUTION RECORD
B-0934 · 120,000 units
Actual material issues, observations, exceptions, and review decisions for this batch.
Actual work linked to its approved source
A new recipe revision triggers an impact review of related instructions, training, and verification. An in-flight batch retains the revision that governed its execution.
Useful intelligence. Explicit authority.
Start the investigation with the context assembled.
Give AI the records and relationships needed to produce a useful draft. Keep the decision with the accountable person.